Multiple Dose Japanese Bridging Study

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• Healthy Japanese and non-Japanese subjects

• Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry

• Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country

• BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects

• Men ages 20 to 45 years

Exclusion Criteria:

• Serum creatinine values above the normal range

• Urine protein or blood levels above the normal range

• Liver function tests above the normal range

• TSH, free T3, or free T4 outside the normal range

• Amylase or lipase levels above the normal range

• Positive Fecal Immunochemical Test (FIT™)